Actively Recruiting
A Prospective, First in Human Pivotal Study to Evaluate the Adaptive Tip Catheter Used to Treat Acute Ischemic Stroke Patients During Mechanical Thrombectomy
Led by Neuravi Limited · Updated on 2026-06-05
74
Participants Needed
15
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the Adaptive Tip Catheter (ATC) as a first-line direct aspiration thrombectomy technique for patients suffering from acute ischemic stroke in the anterior circulation. This pivotal study aims to assess how well the ATC works when used during mechanical thrombectomy, a procedure to remove clots from blood vessels in the brain. The study is sponsored by Neuravi Limited and follows patients for 90 days after the procedure. Participants will undergo mechanical thrombectomy using the Adaptive Tip Catheter alone as the first attempted device for up to three passes or until final reperfusion is achieved. The procedure focuses specifically on treating acute ischemic stroke in the anterior circulation. Patients will be observed during the procedure and followed for 90 days post-treatment to monitor outcomes and safety. During the study, researchers will assess reperfusion success after the third pass, as evaluated by an independent imaging core lab, along with first pass and final procedural reperfusion. Participants will be monitored for vessel damage, symptomatic intracranial hemorrhage within 24 hours, all-cause mortality, and functional outcomes measured by the Modified Rankin Scale at 90 days. The study includes various assessments and imaging to evaluate treatment effects and safety over the follow-up period.
CONDITIONS
Brief Title
A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 90 years at the time of consent
- Signs and symptoms consistent with acute ischemic stroke in the anterior circulation treatable with endovascular thrombectomy
- Endovascular treatment can be initiated within 24 hours from time last known well
- Baseline National Institutes of Health Stroke Scale (NIHSS) score of 6 or higher
- Baseline Alberta Stroke Program Early CT Score (ASPECTS) of 3 or higher
- Signed informed consent or investigator statement for emergency procedure obtained as per regulations
You will not qualify if you...
- Known pregnancy or breastfeeding
- Life expectancy less than 90 days prior to stroke onset
- Known bleeding disorder or coagulation factor deficiency, or oral anticoagulant therapy with INR greater than 3.0
- Bilateral stroke or stroke in multiple vascular territories
- Chronic intracranial occlusion
- Recent or fresh hemorrhage seen on CT or MRI
- CT or MRI showing mass effect
- Current participation in an interventional clinical trial that may affect study results
- Pre-existing arterial disease affecting treatment or outcome
- Occlusion or stenosis limiting device access or requiring acute stenting
- Multiple cerebrovascular occlusions not downstream from each other
- Excessive vascular access tortuosity preventing catheter use
- Baseline expanded thrombolysis in cerebral infarction (eTICI) score greater than 1
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day plus immediate recovery period
Participants undergo mechanical thrombectomy using the Adaptive Tip Catheter as the first attempted device for treatment of acute ischemic stroke.
1 procedure visit (in-person)
Duration - 90 days post-procedure
Participants are followed for safety and effectiveness assessments after the procedure.
Approximately 3 visits over 90 days
Trial Site Locations
Total: 15 locations
1
UZ Antwerpen
Edegem, Belgium, 2650
Actively Recruiting
2
Ghent University Hospital
Ghent, Belgium, 9000
Actively Recruiting
3
Universitair Ziekenhuis Leuven
Leuven, Belgium, 3000
Actively Recruiting
4
CHU Bordeaux
Bordeaux, France, 33076
Not Yet Recruiting
5
CHU Nantes
Nantes, France, 44093
Not Yet Recruiting
6
CHU Pitie Salpetriere
Paris, France, 75013
Not Yet Recruiting
7
Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
Toulouse, France, 31059
Actively Recruiting
8
CHRU de Tours
Tours, France, 37000
Not Yet Recruiting
9
Universitaetsklinikum Heidelberg
Heidelberg, Germany, 69120
Not Yet Recruiting
10
Universitatsklinikum Schleswig Holstein Kiel
Kiel, Germany, 24105
Actively Recruiting
11
Universitaetsmedizin Mainz
Mainz, Germany, 55101
Actively Recruiting
12
Stadtisches Klinikum Solingen gemeinnutzige GmbH
Solingen, Germany, 42653
Actively Recruiting
13
Beaumont Hospital
Dublin, Ireland, 00000
Not Yet Recruiting
14
VUMC Amsterdam
Amsterdam, Netherlands, 1105 AZ
Withdrawn
15
Maastricht University Medical Centre
Maastricht, Netherlands, 6229 HX
Not Yet Recruiting
Research Team
A
Adriana Popovici
A
Arnaud Nicolas, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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